Status:
COMPLETED
e-BioMatrix Canada Registry
Lead Sponsor:
Biosensors Europe SA
Conditions:
Device Related MACE and Bleeding
Eligibility:
All Genders
18+ years
Brief Summary
Prospective, multi-center registry to be conducted at 6 Canadian interventional cardiology centers. The e-BioMatrix data will be compared with a historical control group, the Cypher arm of the Biosens...
Detailed Description
The purpose of this registry is to capture additional "on-label" clinical data of the CE-marked BioMatrix Flex™ (BA9™-Eluting) stent system in relation to safety and effectiveness. This prospective, ...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Presence of coronary artery stenosis in one or two native coronary arteries from 2.25 to 4.0 mm in diameter that can be each covered with one BioMatrix FlexTM stent
- Up to two lesions in two separate vessels to be treated
Exclusion
- Inability to provide informed consent;
- Life expectancy less than 2 years;
- Staged procedure planned within index procedure hospitalization;
- ST elevation myocardial infarction;
- Angiographic evidence of thrombus;
- EF \< 20%;
- Coronary artery bypass graft-lesion incl SVG;
- Chronic total occlusion of the target lesion;
- In stent restenosis
- Bifurcation requiring 2 or more stents;
- Left Main lesion;
- Renal insufficiency (serum creatinine \> 260 µmolmol/L or \> 2.95mg/dl)
- Multi-vessel disease with more than two vessels affected;
- Have known intolerance to aspirin, clopidogrel, heparin, stainless steel, Biolimus A9 (limus compounds), contrast material;
- Currently participating in another study;
- Planning to have surgery within 6 months (excluding surgery which DAPT is maintained throughout the peri-surgical period);
- Woman of childbearing potential with a positive pregnancy test.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
535 Patients enrolled
Trial Details
Trial ID
NCT01915628
Start Date
May 1 2013
End Date
September 1 2017
Last Update
May 7 2019
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Victoria Heart Institute Foundation
Victoria, British Columbia, Canada, V8R 4R2
2
Sunnybrook Health Sciences
Toronto, Ontario, Canada, M4N 3M5
3
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
4
Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1